Enhancing Participation In the Community by Improving Wheelchair Skills: Phase 2 (EPIC WheelS)
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| First Received Date ICMJE | July 13, 2012 | ||||||||||||
| Last Updated Date | July 16, 2012 | ||||||||||||
| Start Date ICMJE | August 2012 | ||||||||||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score [ Time Frame: Baseline and follow-up (1 month) ] [ Designated as safety issue: Yes ] The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01644292 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Enhancing Participation In the Community by Improving Wheelchair Skills: Phase 2 | ||||||||||||
| Official Title ICMJE | Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): Phase 2 | ||||||||||||
| Brief Summary | The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills home training program for older adults in preparation for a third phase feasibility study. |
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| Detailed Description | Many older adults rely on a manual wheelchair for community mobility but are not provided with skills for independent and effective use. Suboptimal or disuse of the wheelchair results in substantial social costs such as reduced engagement in meaningful activity, social isolation, and higher caregiver burden. This represents a poor use of financial resources, including the cost of wheelchair acquisition and demands for attendant care. Access to skills training is constrained by the cost and limited availability of skilled therapists, the demands of patient and clinician travel, and lack of programs designed specifically for the needs of older adults. Enhancing Participation In the Community by improving Wheelchair Skills (EPIC WheelS) is an individualized home-training program that optimizes learning for older adults while limiting the demands on expert clinician trainers. It is delivered using a portable computer tablet that allows interactive learning, customized updating, and communication with an expert trainer. A monitored, home program that is effective and efficient for older adults has potential application for other target groups as well, particularly those with limited access to rehabilitation services in rural and remote locations. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 1 | ||||||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Older Adult Manual Wheelchair Users | ||||||||||||
| Intervention ICMJE | Other: EPIC WheelS
EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment. |
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| Study Arm (s) | Experimental: Training Intervention
Intervention: Other: EPIC WheelS |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||||||
| Estimated Enrollment ICMJE | 5 | ||||||||||||
| Estimated Completion Date | December 2012 | ||||||||||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 55 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01644292 | ||||||||||||
| Other Study ID Numbers ICMJE | H2012:069 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | University of Manitoba | ||||||||||||
| Study Sponsor ICMJE | University of Manitoba | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Manitoba | ||||||||||||
| Verification Date | July 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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